EXPANDED COVERAGE FOR ULTRASOUND STIMULATION OF FRACTURES PROPOSED
The Centers for Medicare & Medicaid Services (CMS) today announced it is expanding Medicare coverage of implantable cardioverter defibrillators (ICDs), a move expected to save thousands of lives a year.
“Our expanded coverage for devices to prevent sudden death in people with heart disease will save thousands of lives each year and improve the quality of life for America’s seniors,” said CMS Administrator Mark B. McClellan, M.D., Ph.D. “By increasing the use of defibrillators we are striking a blow against the leading cause of death among older Americans.”
“This coverage decision demonstrates our determination to save lives by making prompt coverage decisions using new medical evidence, and to improve the evidence available to doctors and patients to help them get the greatest benefits while avoiding unnecessary risks and costs,” McClellan said.
CMS also announced that it proposes to expand Medicare coverage of ultrasound stimulation for non-healing fractures to beneficiaries enrolled in comparative prospective clinical trials.
Both decisions provide for developing further evidence that will lead to more informed medical decisions, resulting in higher quality care and greater value in health care spending.
The expansion will increase the number of Medicare beneficiaries eligible for an ICD by one-third, to nearly 500,000. CMS expects to provide this therapy to at least 25,000 additional patients in the first year of coverage, potentially saving up to 2,500 lives.
Coronary heart disease is the single most common cause of death in the United States . Sudden death, frequently from heart arrhythmias, is estimated to account for approximately 50 percent of all coronary heart disease deaths. An ICD is implanted in a patient’s chest to monitor the heart’s rhythm and deliver an electrical shock when a life-threatening arrhythmia is detected.
The expanded ICD coverage was prompted by results of a well-designed trial, labeled the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), sponsored by the National Heart, Lung and Blood Institute. It is a prospective, randomized trial to compare the effectiveness of medication, implantable defibrillators and placebo on survival in patients with heart failure.
Based on the clinical trial results, published in the New England Journal of Medicine on January 20, 2005, the decision provides coverage for the population studied in the trial, including patients with heart failure and poor function of their left ventricle.
In addition, careful analysis of the new data from this trial in combination with data from all previous ICD trials showed that patients with a certain finding on electrocardiograms of their heart, called a narrow QRS, may also derive a small but measurable, significant benefit from having an ICD.
As part of the coverage decision, CMS will require the submission of specific demographic, clinical, provider and device data into a data registry at the time of the procedure. This process will ensure that patients are receiving high quality, medically necessary care, and will also provide valuable new information about the optimal use of ICDs. The ICD Abstraction Tool is available on the Quality Network Exchange, a system that hospitals currently use to abstract and send quality measures to CMS.
CMS is working with cardiology specialty societies, product manufacturers, health plans and experts from the clinical community to develop a follow-on registry that will continue to collect the important data that the QNET registry has collected as well as other data that will answer additional important questions on the use of ICDs.
Leaders from the ICD industry have also agreed to support additional studies that will address some of the remaining questions on the optimal use of ICDs, including identification of patient populations that benefit most from ICDs.
“Support for practical studies as part of our coverage decisions is designed to ensure that patients are getting the beneficial care they need, and to provide additional evidence to help doctors and patients get the most out of new technologies,” McClellan said. “We want to deliver high quality care while also developing better information about which patients benefit most from having an ICD.”
“With more accurate information, clinicians can do more to ensure that patients at the highest risk who can benefit most from the device can get them,” said Sean Tunis, M.D., the chief medical officer for CMS. “We will continue to work with experts and stakeholders to identify the best ways to support the development of this information to help our beneficiaries get even better care.”
Some future Medicare coverage decisions may also link coverage to the collection of additional prospective clinical data. The CMS Council on Technology and Innovation is developing a draft guidance document on this policy approach in order to ensure that this aspect of the coverage process reflects a systematic, science-based approach that is predictable and transparent. An open door forum on this topic will be held on Feb 14 2005 to obtain public input on linking coverage to practical trials and registries, prior to the development of the draft guidance. In addition, comments on this approach can be submitted through the CTI website at http://www.cms.hhs.gov/providers/cti. The initial draft guidance will be issued by March 31, 2005, at which time additional public feedback will be solicited.
CMS has determined that the national coverage determination (NCD) for ICDs meets the significant cost threshold of the Social Security Act and CMS regulations. Thus, CMS will make payments on a fee-for-service basis through the Medicare fiscal intermediaries and carriers through December 31, 2005. Medicare Advantage organizations are not required to assume risk for the costs of this service r benefit until the contract year for which payments are appropriately adjusted to take into account the cost of the service. Medicare Advantage enrollees will be liable for any applicable coinsurance under original fee-for-service Medicare.
The proposed Medicare coverage decision on ultrasound stimulation for fractures, also announced today, would expand coverage for fractures that have not been healing properly (nonunion fractures) when the provider is participating in and patients are enrolled in a comprehensive prospective clinical trial approved by Medicare.
Ultrasound stimulation, a non-invasive treatment of nonunion fractures, has been covered for Medicare beneficiaries since 2000. A nonunion fracture is a fracture that has had no visible or x-ray signs of healing for at least three months and healing will not proceed without some type of intervention. The proposed coverage expansion would remove a requirement that surgery must have failed before ultrasound can be used as a treatment only if the beneficiaries is enrolled in a prospective comparative clinical trial with the goals of monitoring, evaluating, and improving clinical outcomes.
CMS will accept public comment on the proposed NCD regarding ultrasound stimulation proposal for 30 days and will publish a final decision within 90 days.
Medicare coverage decisions and proposed coverage decisions can are available on the CMS web site at www.cms.hhs.gov/coverage.